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A Rapid Systematic Review Direct and indirect evidence of ecacy and safety of rapid exercise tests for exertional desaturation in Covid-19: A rapid systematic review Asli Kalin University of Oxford Babak Javid University of California San Francisco Matthew Knight ( [email protected] ) West Hertfordshire Hospitals NHS Trust https://orcid.org/0000-0003-1761-0115 Matt Inada-Kim Hampshire Hospitals NHS Foundation Trust Trisha Greenhalgh University of Oxford https://orcid.org/0000-0003-2369-8088 Research Keywords: Covid-19, desaturation, 1-minute sit-to-stand test, 6-minute walk test, 40-step test, normoxia, silent hypoxia, hidden hypoxia Posted Date: February 10th, 2021 DOI: https://doi.org/10.21203/rs.3.rs-105883/v2 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Version of Record: A version of this preprint was published on March 16th, 2021. See the published version at https://doi.org/10.1186/s13643-021-01620-w. Page 1/20 Abstract Background Even when resting pulse oximetry is normal in the patient with acute Covid-19, hypoxia can manifest on exertion. We summarise the literature on the performance of different rapid tests for exertional desaturation and draw on this evidence base to provide guidance in the context of acute COVID-19. Main research questions 1. What exercise tests have been used to assess exertional hypoxia at home or in an ambulatory setting in the context of Covid-19 and to what extent have they been validated? 2. What exercise tests have been used to assess exertional hypoxia in other lung conditions, to what extent have they been validated and what is the applicability of these studies to acute Covid-19? Method AMED, CINAHL, EMBASE MEDLINE, Cochrane and PubMed using LitCovid, Scholar and Google databases were searched to September 2020. Studies where participants had Covid-19 or another lung disease and underwent any form of exercise test which was compared to a reference standard were eligible. Risk of bias was assessed using QUADAS 2. A protocol for the review was published on the Medrxiv database. Results Of 47 relevant papers, 15 were empirical studies, of which 11 described an attempt to validate one or more exercise desaturation tests in lung diseases other than Covid-19. In all but one of these, methodological quality was poor or impossible to fully assess. None had been designed as a formal validation study (most used simple tests of correlation). Only one validation study (comparing a 1-minute sit-to-stand test [1MSTST] with reference to the 6-minute walk test [6MWT] in 107 patients with interstitial lung disease) contained sucient raw data for us to calculate the sensitivity (88%), specicity (81%), and positive and negative predictive value (79% and 89% respectively) of the 1MSTST. The other 4 empirical studies included two predictive studies on patients with Covid-19, and two on HIV-positive patients with suspected pneumocystis pneumonia. We found no studies on the 40-step walk test (a less demanding test that is widely used in clinical practice to assess Covid-19 patients). Heterogeneity of study design precluded meta-analysis. Discussion Exertional desaturation tests have not yet been validated in patients with (or suspected of having) Covid-19. A stronger evidence base exists for the diagnostic accuracy of the 1MSTST in chronic long term pulmonary disease, the relative intensity of this test may raise safety concerns in remote consultations or unstable patients. The less strenuous 40-step walk test should be urgently evaluated. Background A substantial proportion of patients with acute coronavirus 19 (Covid-19) develop a potentially critical form of the illness requiring intensive care unit admission [1]. The degree of lung involvement in acute Covid-19 is variable, producing a spectrum of illness from mild upper respiratory tract symptoms to acute respiratory distress syndrome [2]. Patients with mild initial symptoms can rapidly deteriorate to severe or critical cases. In hospitalised patients, hypoxaemia and the need for oxygen are independent predictors of severe outcomes [3, 4]. The usual time from symptom onset to the development of severe hypoxemia is between 7 and 12 days [5, 6]. Recent prognostic tools such as the 4C score have emphasised the importance of identifying hypoxia early [3, 7] and there are physiological reasons for managing this hypoxia actively [8, 9]. Page 2/20 The poor correlation between both subjective feeling of shortness of breath (dyspnoea) and objective measures of breathlessness and hypoxia in patients with Covid-19 has resulted in UK guidelines recommending that the assessment of the breathless, unwell or high-risk patient should include oximetry [5]. For example, a retrospective cohort study of 64 Covid-19 patients considered eligible for home oximetry monitoring showed that the presence of dyspnoea had a positive predictive value of only 42% for hypoxemia and absence of dyspnoea had a negative predictive value of 86% for excluding it [10]. Indeed, the mismatch between relatively mild subjective respiratory distress and objective evidence of peripheral hypoxia is now recognised as a feature of Covid-19 and has been termed “silent” or “happy” hypoxemia [11, 12]. Similarities with PCP have been drawn by others, and whilst a detailed discussion of pulmonary physiology is outside the scope of this literature review, this feature has been attributed to moderate to severe ventilation-perfusion mismatch [11], intra-pulmonary shunting, loss of lung perfusion regulation, intravascular microthrombi or reduced lung compliance [12, 13]. Hypoxia is common in acute severe Covid-19. Richardson et al found that 28% of 5700 patients admitted to hospital with acute Covid-19 in New York City were suciently hypoxemic to need supplemental oxygen on admission [14]. Yet dyspnoea was reported in only 18.7% of 1099 hospitalized Covid-19 patients, despite low PaO2/FiO2 ratios and requirement for supplemental oxygen in 41% [15]. In a study of the 19 worst-affected countries worldwide, Goyal et al reported that rates of mortality were signicantly higher in those countries where policies recommended lower oxygen saturations before administering supplemental oxygen than in those that aimed to normalised saturations, though there may have been other explanations for these differences including different degrees of preparedness for a pandemic and different incidence rates [16]. It is widely reported that some patients with acute Covid-19 have normal pulse oximetry at rest but their readings deteriorate on exertion (unpublished data). UK national guidance, for example, recommends the use of exertional desaturation tests to detect early deterioration of patients with COVID-19 in community and emergency settings [17-19]. In consensus exercises, front-line clinicians have identied the late transfer of patients with exertional desaturation (i.e. a fall of 3% or more in pulse oximetry reading on exercise) as a possibly remediable cause of poor outcome [20]. Several publications recommend or suggest the use of exertional tests in the assessment of COVID-19 patients. Mantha et al discuss the use of a modied 6-minute walk test (6MWT), wearing masks and only in those under 70, on day 4 or 5 of clinical illness to risk-stratify patients [6]. This suggestion is echoed by Noormohammadpour and Abolhasani, who propose that deterioration in the 6MWT test can be used to identify those who need referral to hospital [21]. Pandit et al recommend the 6MWT for those under 60 who are not short of breath at rest and a 3-minute walk test (3MWT) for those over 60 who are unable to complete the longer test, but warn that the test is contra-indicated in patients who are hypoxic at rest (SpO2 < 94%), short of breath at rest, not able to walk unassisted, have Eisenmenger’s syndrome, severe anaemia, unstable angina or valvular heart disease [2]. They suggest that the 6MWT or 3MWT test can be performed at home or in hospital under the supervision of either a family member or a healthcare professional. These authors dene exertional hypoxia as an absolute drop in oximeter reading by 3% or more from baseline. The level of 3% reduction from normal levels is drawn from the British Thoracic Society emergency oxygen guidelines [22] consensus amongst clinicians and a recent empirical study [23]. In sum, consensus guidance and editorials recommend tests for exertional hypoxia in Covid-19, but the evidence base for these tests has not previously been formally reviewed. Indeed, the prognostic utility of exertional desaturation remains unknown. Another unknown is the safety of such tests in patients with suspected Covid-19, especially when used remotely without a clinician physically present. Establishing a validated tool to assess exertional desaturation will help to ensure that future research on this topic can be undertaken in a consistent way. Review objective and research questions The overall objective of this rapid review was to examine the published evidence base for the use of rapid exercise tests and assess their application to the assessment of patients with acute COVID-19. We were particularly interested in tests that could be used outside of the hospital setting, since the reality of acute Covid-19 often involves a remote assessment (with the patient at home at a distance from the clinician) or one in a bespoke ambulatory setting such as a “hot hub” (where exercise tests may Page 3/20 be performed outside in car parks, for example, for infection control reasons). We were, however, aware that when we began this study, little or no direct research evidence existed on the use of these tests in patients with Covid-19. The research questions were: 1. What exercise tests have been used to assess exertional hypoxia at home or in an ambulatory setting in the context of Covid-19 and to what extent have they been validated? 2.
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